麻豆传媒

Compared with insertion of a passive abdominal drain after distal pancreatectomy, which has been standard practice, not inserting a drain did not increase rates of major morbidity and reduced the detection of grade B or C postoperative pancreatic fistula (POPF), the randomized non-inferiority PANDORINA trial showed.

In the intention-to-treat analysis, the rate of major morbidity was non-inferior in the no-drain group compared with the drain group: 15% versus 20% (P=0.0022), and was 16% versus 20% in the per-protocol analysis (P=0.0045), reported Marc G. Besselink, MD, of the University of Amsterdam, and colleagues.

Grade B or C POPF was observed in 12% of patients in the no-drain group compared with 27% of those in the drain group (P<0.0001) in the intention-to-treat analysis, they noted in the .

Besselink and team explained that POPF can lead to post-pancreatectomy hemorrhage, intra-abdominal infected collections, and sepsis.

"Some have argued that prophylactic abdominal drainage after distal pancreatectomy can be omitted, especially in patients considered low risk, as leaks are non-infected, unlike after a pancreatoduodenectomy during which the intestinal tract is opened," they wrote. "Moreover, a no-drain policy would free patients from the burden of a surgical drain and eliminate the risk of the drain actually facilitating infection with commensal skin flora and potentially converting a self-limiting and contained collection to a POPF."

Notably, three patients in the no-drain group died within 90 days, with the cause of death not considered related to the trial in two patients. The third patient, who had an American Society of Anesthesiology (ASA) score of 4, died after sepsis and a watershed cerebral infarction at second admission, leading to multiple organ failure. No patients in the drain group died within 90 days.

A showed similar morbidity rates between patients who did and not receive a drain after a distal pancreatectomy. A meta-analysis of five studies showed a lower rate of major morbidity (risk ratio 0.55, 95% CI 0.42-0.72) and grade B or C POPF (risk ratio 0.82, 95% CI 0.68-0.99) in the no-drain versus drain group.

However, clinical practice has not changed after these findings, Besselink and team noted.

In an , Ulla Klaiber, MSc, and Oliver Strobel, MD, of the Medical University of Vienna, pointed out that despite efforts to improve outcomes after pancreatic surgery, postoperative morbidity has remained high.

"Proponents of prophylactic drainage argue that complications, including POPF, can be detected and controlled before life-threatening sequelae occur and that reinterventions for infectious collections can be avoided," they wrote. "However, intra-abdominal drains can lead to the risk of ascending infections and might contribute to postoperative morbidity themselves."

"The results of the PANDORINA trial are of great interest and are relevant for all pancreatic surgeons, as they provide high-level evidence for the non-inferiority of a no-drain policy after distal pancreatectomy, even though prophylactic drainage is still the standard of care in most centers," they concluded.

This open-label trial was conducted at 10 sites in the Netherlands and two sites in Italy from October 2020 through April 2023. The researchers enrolled patients who were undergoing minimally invasive or open distal pancreatectomy with or without splenectomy. They excluded patients with an ASA physical status of 4-5 or WHO performance status of 3-4, added by amendment after the death of a patient with an ASA 4 due to a pre-existing cardiac condition.

Patients were stratified by annual center volume (<40 or ≥40 distal pancreatectomies) and low risk or high risk of grade B or C POPF. High risk was defined as a pancreatic duct of more than 3 mm in diameter, a pancreatic thickness at the neck of more than 19 mm, or both, based on the Distal Pancreatectomy Fistula Risk Score.

Of 376 patients who were screened for eligibility, 138 were randomly assigned to the no-drain group (mean age 62.9, 54% women) and 144 to the drain group (mean age 61.9, 51% women). Most patients in both groups had a preoperative working diagnosis of pancreatic ductal adenocarcinoma, a pancreatic neuroendocrine tumor, or an intraductal papillary mucinous neoplasm. Patients were followed for 90 days after surgery.

In a post-hoc subgroup analysis of patients at low risk of POPF, the risk of major morbidity was significantly lower in the no-drain group versus the drain group (risk difference -14.4 percentage points, 95% CI -28.4 to -0.4). The risk of major morbidity was not significantly different between no-drain and drain in the intermediate-risk and high-risk POPF groups.

The authors noted several limitations to their study, including the fact that specific drain-related patient symptoms or complications were not documented, which could have provided insights into patient satisfaction. Furthermore, the exclusion of patients with ASA scores of 4-5 and WHO scores of 3-4 makes the study findings inapplicable to this category of patients.

Comment